Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Study of the Safety of Ramelteon in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease
The purpose of this study is to determine if ramelteon has respiratory depressant effects in subjects with moderate to severe chronic obstructive pulmonary disease.
About 30% of the adult population report sleep disturbance and 10% meet diagnostic criteria
for chronic insomnia. While 20 -25% of these individuals have primary insomnia the vast
majority have an additional condition such as chronic obstructive pulmonary disease. Several
studies have looked at this and have estimated that 30% to 48% of the general population is
affected at some time in their life with a form of insomnia that goes on for several months,
and about one third of those are described as severely affected. Daytime symptoms of
insomnia include tiredness, lack of energy, difficulty concentrating and irritability.
Recent epidemiologic research focusing on the quality of life has identified significant
insomnia related conditions or diseases that relate to work productivity, health care
utilization, and risk of depression. Insomnia is associated with diminished work output,
absenteeism and greater rates of accidents.
Ramelteon, is being developed as a sleep promoting agent based on agonism of melatonin
receptor subtype 1 and 2. Ramelteon is marketed in the United States as Rozeremâ„¢ for the
treatment of insomnia characterized by difficulty with sleep initiation.
Sleep problems are common in patients with chronic obstructive pulmonary disease. There is
evidence that traditional hypnotics can cause adverse respiratory effects in insomniac
populations with respiratory disorders, and so the safety and efficacy of new hypnotic
agents must be ascertained in this group of patients.
This study will examine if ramelteon has respiratory depressant effects in subjects with
moderate to severe chronic obstructive pulmonary disease. Study participation is anticipated
to be about 6 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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